Urinary incontinence device

ABSTRACT

A urinary incontinence device for alleviating female urinary incontinence is disclosed. The urinary incontinence device includes a resilient member and a non-absorbent positioned adjacent to the resilient member. The non-absorbent is constructed from a fibrous material wherein the fibers do not absorb significant quantities of moisture within the fibers. The resilient member and the non-absorbent are rolled into an elongated softwind with the resilient member located adjacent to an end thereof. The softwind has a larger diameter at one end. The softwind is then radially compressed into an elongated pledget having an insertion end, a trailing end and a uniform cross-sectional area therebetween. The resilient member is capable of expanding the insertion end of the pledget to provide a supportive backdrop for a woman&#39;s urethra when inserted into a woman&#39;s vagina.

FIELD OF THE INVENTION

[0001] This invention relates to a urinary incontinence device foralleviating female urinary incontinence and a method of making the same.More specifically, this invention relates to a urinary incontinencedevice for alleviating female urinary incontinence during episodes ofincreased intra-abdominal pressure.

BACKGROUND OF THE INVENTION

[0002] The primary etiological factor producing genuine stress urinaryincontinence is the incomplete transmission of abdominal pressure to theproximal urethra due to displacement from its intra-abdominal position.Some women, especially women who have given birth to one or morechildren, and older women, can experience incidences of involuntaryurine loss due to stress urinary incontinence or combined stress andurge incontinence. A sneeze or cough can increase the intra-abdominalpressure impinging on a person's bladder and cause the involuntaryrelease of urine. The frequency and severity of such urine loss canincrease as the muscles and tissues near the urethro-vaginal myofascialarea grow weaker. It has also been recognized that the urinary sphinctermuscle, which is located at the upper end of the urethra, adjacent tothe bladder, works well at sealing off the passing of urine from thebladder to the urethra when it has a round or circular cross-sectionalconfiguration. Support of the proximal urethra elevates it above thepelvic floor and subjects it to increases in intra-abdominal pressure,thus allowing compression and maintenance of continence. However, whenthis passageway becomes distorted into a cross-sectional configurationhaving more of an elliptical or oval appearance, the sphincter musclecan not close properly, therefore, the tendency for involuntary urineloss increases. One must remember that the urethra and vagina are notseparate structures. Because of their common derivation from theurogenital sinus, they are fused in the distal two thirds of theurethra. In this region, they are bound together by the endopelvicconnective tissue so that the support of the urethra depends not only onthe attachments of the urethra itself to adjacent structures but also onthe connection of the vagina and periurethral tissues to the pelvicwall.

[0003] As the world's female population ages, there is anever-increasing need for a non-surgical method or measure to reduce theinvoluntary urine loss commonly associated with stress urinaryincontinence. Today, there are a number of specialized productsavailable for this purpose. Most of these products can only be purchasedwith a prescription and they need to be properly sized, physicallyinserted and/or adjusted by a medical doctor or a nurse practitioner inorder for them to perform correctly. Few, if any, products arecommercially available in the United States, without a prescription, toprevent involuntary urine loss from stress urinary incontinence.

[0004] In view of the lack of commercially available, non-prescriptionurinary incontinence prevention or mitigation devices, it is recognizedthat there is a need for a urinary incontinence device that can bepurchased without a prescription. There is also a need for a urinaryincontinence device that is uncomplicated and therefore more userfriendly and can be managed by the consumer without the intervention ofa medical practitioner. Furthermore, there is a need for a urinaryincontinence device which is easy for women to insert into and removefrom their bodies, be more comfortable to wear and provide psychologicaland realistic assurance that it is capable of properly performing overan extended period of time.

SUMMARY OF THE INVENTION

[0005] Briefly, this invention relates to a urinary incontinence devicefor alleviating female urinary incontinence. The urinary incontinencedevice includes a resilient member and a non-absorbent positionedadjacent to the resilient member. The non-absorbent is constructed froma fibrous material wherein the fibers do not absorb significantquantities of moisture within the fibers. The resilient member and thenon-absorbent are rolled into an elongated softwind with the resilientmember located adjacent to an end thereof. The softwind has a largerdiameter at one end. The softwind is then radially compressed into anelongated pledget having an insertion end, a trailing end and a uniformcross-sectional area therebetween. The resilient member is capable ofexpanding the insertion end of the pledget to provide a supportivebackdrop for a woman's urethra when inserted into a woman's vagina.

[0006] The general object of this invention is to provide a urinaryincontinence device for alleviating female urinary incontinence. Morespecifically, this invention relates to a urinary incontinence devicefor alleviating female urinary incontinence during episodes of increasedintra-abdominal pressure.

[0007] A more specific object of this invention is to provide a urinaryincontinence device that is placed in a woman's vagina and providessupport to a woman's urethra to prevent involuntary urine loss commonlyassociated with stress urinary incontinence.

[0008] Another object of this invention is to provide a urinaryincontinence device that is simple to use, easy to insert and remove,and which is comfortable to wear.

[0009] A further object of this invention is to provide a urinaryincontinence device that can be manufactured and sold for a reasonablecost.

[0010] Still another object of this invention is to provide a urinaryincontinence device that can be purchased by a consumer without aprescription.

[0011] Still further, an object of this invention is to provide aurinary incontinence device that does not disrupt the availability ofnormal vaginal secretions, which are necessary for a healthy vaginalenvironment.

[0012] Other objects and advantages of the present invention will becomemore apparent to those skilled in the art in view of the followingdescription and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0013]FIG. 1 is a mid-sagittal section of a human torso showing aurinary incontinence device positioned in the vaginal canal andcooperating with the symphysis pubis to allow the urethral tube to becompressed upon itself and alleviate urinary incontinence duringepisodes of increased intra-abdominal pressure.

[0014]FIG. 2 is a sectional view taken along line 2-2 of FIG. 1 when theinsertion end of the urinary incontinence device is in an expandedcondition closing off the cross-section of the vaginal canal andproviding a supportive backdrop for closing off the urethra.

[0015]FIG. 3 is a perspective view of a cover, a non-absorbent and aresilient member shown in a flat orientation before being rolled andcompressed to form a urinary incontinence device.

[0016]FIG. 4 is a perspective view of the three layers depicted in FIG.3 after being rolled up along the longitudinal axis X-X to form anelongated softwind having an enlarged end.

[0017]FIG. 5 is a perspective view of an elongated pledget having aninsertion end, a trailing end and a uniform cross-sectional areatherebetween that is formed by compressing the softwind shown in FIG. 4.

[0018]FIG. 6 is a side view of the pledget housed in an applicator.

[0019]FIG. 7 is a perspective view of an alternative embodiment of acover, a non-absorbent and a relatively short resilient member shown ina flat orientation before being rolled and compressed to form a urinaryincontinence device.

[0020]FIG. 8 is a perspective view of the three layers depicted in FIG.7 after being rolled up along the longitudinal axis X-X to form anelongated softwind having an enlarged end.

[0021]FIG. 9 is a perspective view of an elongated pledget having aninsertion end, a trailing end and a uniform cross-sectional areatherebetween that is formed by compressing the softwind shown in FIG. 8.

[0022]FIG. 10 is a flow diagram of a method of forming a urinaryincontinence device.

[0023]FIG. 11 is a flow diagram of an alternative method of forming aurinary incontinence with a cover and housing the device in anapplicator.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0024] Referring to FIGS. 1 and 2, a human torso 10 of a female isdepicted showing the vagina 12, a cervix 14, a uterus 16, a urethra 18,a bladder 20 and a symphysis pubis 22. The vagina 12 has an introitalopening 24 which exits the human body 10 and contains a vaginal canal 26which extends from the introital opening 24 to the cervix 14. Thevaginal canal 26 has a length which ranges from between about 4 inchesto about 6 inches (about 102 millimeters (mm) to about 153 mm) in mostwoman. The cervix 14 is the entrance to the womb and is located betweenthe upper aspect of the vaginal canal 26 and the uterus 16. A rectum 27is located posterior to the vagina 12. The vaginal canal 26 has an innerperiphery 28. The inner periphery 28 is made up of right and leftlateral walls, 30 and 32 respectively, an anterior wall 34 and aposterior wall 36, see FIG. 2. The four walls 30, 32, 34 and 36encompass the entire 360 degrees of the inner periphery 28. The anteriorwall 34 is located closest to the urethra 18 and the urethra 18 islocated between the symphysis pubis 22 and the vagina 12. The vaginalcanal 26 can be divided into three approximately equal sections, eachrepresenting a third of the overall length. Each section isapproximately 2 inches (approximately 51 mm) in length. The middle thirdof the vaginal canal 26 is the most important section for alleviatingfemale urinary incontinence because of its proximity to the urethra 18and is the location where a urinary incontinence device should bepositioned. The middle third of the vaginal canal 26 also ishorizontally offset from the symphysis pubis 22, which is a bonyprominence situated adjacent to a front portion 38 of the human torso10. Cooperation between a urinary incontinence device positioned in themiddle third of the vagina 12 and the symphysis pubis 22 allows theurethra 18 to be compressed upon itself thereby alleviating involuntaryurine flow from the bladder 20.

[0025] The urethra 18, also referred to as a urethral tube, is a hollowtube which extends from a first opening 40, which exits the human body10, to a second opening 42 situated at the lower surface of the bladder20. The urethra 18 has a length of about 1.5 inches (about 38 mm) inmost women. The urethral 8 functions to discharge urine, which istemporarily stored in the bladder 20, from the human body. The urethra18 has a plurality of urethral sphincter muscles 44 located along thelength of its inner periphery. The urethral sphincter muscles 44 aresituated below the opening 42 and are ringlike muscles that normallymaintains constriction of the urethra 18 to prevent the passage of urinetherethrough. The relaxation of the urethral sphincter muscles 44 bynormal physiological functioning will permit urine to be voluntarilyexpelled from the human body.

[0026] Still referring to FIG. 1, the human torso 10 further includesmusculature and body tissue located in the urethro-vaginal myofascialarea 46 which is situated between the vagina 12 and the symphysis pubis22. The bladder 20 lies posterior to the symphysis pubis 22 and isseparated from the rectum 27 by the vagina 12 and the uterus 16. Theureters (not shown), which transport urine from the kidneys to thebladder 20, pass from the pelvis to the posterior aspect of the urinarybladder 20. The fundus vesicae 48, into which both of the uretersterminate, is located adjacent to the anterior wall 34 of the vagina 12.

[0027] Referring to FIGS. 1-2, a urinary incontinence device 50 is shownpositioned in the middle third of the length of the vaginal canal 26.The urinary incontinence device 50 is designed to bridge across thevagina 12 and supports the musculature and body tissue located in theurethro-vaginal myofascial area 46. In FIG. 2, the urinary incontinencedevice 50 is shown in an expanded state wherein the resilient portion ofthe urinary incontinence device 50 has expanded outward toward itsoriginal shape. In the expanded state, the insertion end of the urinaryincontinence device 50 has a greater diameter and occupies an overalllarger cross-sectional area than the narrow end. The insertion end ofthe urinary incontinence device 50 extends radially outward and is inintimate contacts with the entire inner periphery of the vaginal canal26. In other words, a portion of the urinary incontinence device 50 isdirectly touching all four interior walls 30, 32, 34 and 36 of thevaginal canal 26 and is providing a supportive backdrop for the urethraltube 18. The urethral tube 18 is now compressed sufficiently tointercept the flow of urine and thereby provides support to the urinarysphincter muscle 44 so that it can function properly. By permitting theurethral tube 18 to be compressed upon itself between the urinaryincontinence device 50 and the symphysis pubis 22, one can limit theinvoluntary flow of urine from the bladder 20.

[0028] Referring now to FIGS. 3-5, the urinary incontinence device 50includes a resilient member 52 and a non-absorbent 54. The resilientmember 52 can be a natural or synthetic material that has the ability toquickly recover or return to approximately its original shape and/ordimension once it is placed into a woman's vagina 12. While residingwithin a woman's vagina 12, the resilient member 52 can contracttemporarily by changes in the intra-abdominal pressure as a result oflaughing, sneezing, coughing, or the like. A resilient material is amaterial that can return to or resume its original shape or positionafter being bent, stretched or compressed. The resilient member 52should also exhibit elasticity and flexibility so that it can bestretched or compressed and still retain the capability of returning toapproximately its original shape.

[0029] Two natural materials from which the resilient member 52 can beformed include natural rubber and wool. The number of syntheticmaterials from which the resilient member 52 can be formed is muchgreater. Synthetic materials that can be used include polyolefins,polyurethanes, polyethylene oxide (PEO), polyvinyl alcohol (PVA), aswell as blends thereof. The resilient member 52 can also be formed fromresilient fibers constructed from polyolefin-based fibers, polyethyleneoxide fibers, hydrophobic rayon fibers and the like. Such fibers shouldpreferably have characteristics similar to those of resilient foams. Theresilient fibers can be formed from twisted, curled or cross-linkedcellulose fibers or from a mixture thereof. Furthermore, the resilientmember 52 can be formed from a resilient foam. The resilient foam can bean open cell or a closed cell foam.

[0030] The resilient member 52 can also be made from a wettable foam. Anopen cell wettable foam that works well and has good resilientproperties is commercially available under the trademark ACQUELL®.“ACQUELL” is sold by Sentinel Products Corporation, which has an officeat 70 Airport Road, Hyannis, Mass. 02601. A polyethylene closed cellwettable foam having good flexibility characteristics also works well.This foam is commercially sold under the trademark VOLARA®. “VOLARA” isavailable from Voltex, a Division of Sekisui America Corporation, havingan office at 100 Shepard Street, Lawrence, Mass. 01843.

[0031] The resilient member 52 should also be capable of having what isknown as “dry and wet” expansion characteristics. In other words, theresilient member 52 should be made from a material that is capable ofexpanding or contracting back to or towards its original configurationin a dry state, a wet state or in a semi dry-wet state. Dry expansion ofthe urinary incontinence device 50 is beneficial in that the device doesnot have to be wetted by body fluids before the resilient member 52 iscapable of expanding within a woman's vagina 12.

[0032] In FIG. 3, the resilient member 52 is depicted as a relativelylong narrow strip of material being rectangular in cross-section.However, the resilient member 52 can have a square, circular, oval orany other cross-sectional configuration, if desired. The resilientmember 52 is shown having a length L₁, a width W₁ and a thickness T₁ Thewidth W₁ and the thickness T₁ can remain constant over the entire lengthL₁. If desired, the dimensions of the resilient member 52 can vary sothat the resilient member 52 has a non-uniform cross-section along itslength L₁. The length L₁ of the resilient member 52 can be equal to orless than the length of the non-absorbent 54.

[0033] In the embodiment shown in FIG. 3, the length L₁ of the resilientmember 52 can range from between about 3 inches (about 76 mm) to about 8inches (about 203 mm). Preferably, the length L₁ of the resilient member52 will be from between about 4 inches (about 102 mm) to about 6 inches(about 152 mm). Most preferably, the length L₁ of the resilient member52 will be about 5 inches (about 127 mm). The width W₁ of the resilientmember 52 can range from between about 0.12 inches (about 3 mm) to about1 inch (about 25 mm). Preferably, the width W₁ of the resilient member52 will be from between about 0.25 inches (about 6.4 mm) to about 0.5inches (about 12.7 mm). Most preferably, the width W₁ of the resilientmember 52 will be about 0.375 inches (about 9.5 mm). The thickness T₁ ofthe resilient member 52 can range from between about 0.1 inch (about 2.5mm) to about 0.5 inches (about 12.7 mm). Preferably, the thickness T₁ ofthe resilient member 52 will be from between about 0.1 inches (about 2.5mm) to about 0.4 inches (about 10 mm). Most preferably, the thickness T₁of the resilient member 52 will be less than about 0.3 inches (about 7.6mm).

[0034] When the resilient member 52 has a round or circularcross-sectional configuration, the diameter can range from between about0.1 inch (about 2.5 mm) to about 1.125 inches (about 27.5 mm).Preferably, the diameter of the resilient member 52 will be from about0.1 inch (about 2.5 mm) to about 0.5 inches (about 12.7 mm). Mostpreferably, the diameter of the resilient member 52 will be less thanabout 0.3 inches (about 7.6 mm). For odd cross-sectional shapes, like anoval, a bi-lobal, a tri-lobal, an ellipse, etc. the larger dimensionshould be no greater than about 1.125 inch (about 27.5 mm).

[0035] Referring again to FIG. 3., the non-absorbent 54 is shown havinga first surface 56, a second surface 58, a first end 60, a second end62, a first side edge 64 and a second side edge 66. The non-absorbent 54also has a central longitudinal central axis x-x and a centraltransverse axis y-y. The resilient member 52 is positioned adjacent tothe first surface 56 of the non-absorbent 54. Preferably, resilientmember 52 is positioned parallel to and spaced away from the centrallongitudinal axis x-x. As depicted in FIG. 3, the resilient member 52has a longitudinal side edge 68 and is positioned on the first surface56 such that its side edge 68 is aligned coterminuous with the firstside edge 64 of the non-absorbent 54. This arrangement allows theresilient member 52 to be located approximate one end of the finishedurinary incontinence device 50.

[0036] The non-absorbent 54 has a length L₂ that is equal to or greaterthan the length L₁ of the resilient member 52. In addition, thenon-absorbent 54 has a width W₂ that ranges from between about one toabout eight times the width W₁ of the resilient member 52. Preferably,the width W₂ of the non-absorbent 54 will be from between about two toabout four times the width W₁ of the resilient member 52. Mostpreferably, the width W₂ of the non-absorbent 54 is about three timesthe width W₁ of the resilient member 52. The non-absorbent 54 has athickness T₂ that can be less than, equal to or be greater than thethickness T₁ of the resilient member 52. It should be noted that thenon-absorbent 54 can be a single ply of material or it can beconstructed of two or more plies, such as a laminate.

[0037] The non-absorbent 54 is constructed from materials that exhibitlittle, and preferably no, absorbent characteristics. The non-absorbent54 differs from a catamenial tampon in that it does not function toabsorb body fluid. Instead, the non-absorbent 54 is designed to bridgeacross the vagina 12 and support the musculature and body tissue locatedin the urethro-vaginal myofascial area 46. The urethra 18 can becompressed upon itself sufficiently to interrupt the flow of urine anddoing so can provide support to the urinary sphincter muscles 44 so thatthey can function properly.

[0038] For purposes of this invention, a non-absorbent is defined as amaterial wherein the fibers do not absorb significant quantities ofmoisture within the fibers themselves. It is to be recognized thatvirtually all materials will absorb some small quantity of moisture. Afiber is considered to be non-absorbent for present purposes if it willintrinsically gain no more than about 6 percent in weight when abone-dry fiber is maintained at 21 degrees Celsius and at 65 percentrelative humidity for 24 hours. Non-absorbent materials include but arenot limited to nylons, rayons, spun cellulose, LYCRA®), KEVLAR®, carbonfibers and the like. “LYCRA” and “KELVAR” are trademarks of E. I. DuPontde Nemours & Company having an office at 1007 Market Street, Wilmington,Del. 19801. The non-absorbent 54 can also be formed from a web made frombicomponent fibers which are commercially available from ChissoCorporation having an office at 1411 Broadway, 35^(th) floor, New York,N.Y. Such fibers are sold under the name “Chisso ESC Bicomponent Fiber”and consist of a polypropylene core surrounded by a polyethylene sheath.Fibers that work well have a denier of about 3 and are about 38millimeters in length. Other bicomponent fibers made from polypropylene,polyethylene, etc. are commercially available from suppliers such asExxon and Dow Chemical, as well as from other vendors.

[0039] Alternatively, the non-absorbent 54 could be an absorbentmaterial such as a cotton/rayon blend that has been chemically treatedwith a surfactant to make it non-absorbent. However, materials comprisedof truly non-absorbent fibers work best.

[0040] Referring again to FIG. 3, the second surface 58 of thenon-absorbent 54 is shown being positioned adjacent to a cover 70. Thecover 70 is an optional element and need not be present to form theurinary incontinence device 50. However, the cover 70 can provide asmooth outer surface that may or may not be chemically treated tofacilitate a comfortable insertion and/or removal into and out of awoman's vagina. When present, the cover 70 has a length L₃ that is equalto or greater than the length L₂ of the non-absorbent 54. When thelength L₃ of the cover 70 is longer than the length L₂ of thenon-absorbent 54, it allows the cover 70 to overlap upon itself once thethree layers 52, 54 and 70 are rolled up into a cylindrical form. Theextra length L₃ of the cover 70 facilitates bonding of the cover 70 toitself by heat, pressure, a combination of heat and pressure, or by someother conventional means known to those skilled in the art. If the cover70 is formed from a material that does not readily bond to itself, anadhesive, glue or other bonding or fastening medium can be used.

[0041] The cover 70 also has a width W₃ that can be less than, equal toor greater than the width W₂ of the non-absorbent 54. Preferably, thewidth W₃ of the cover 70 is approximately equal to the width W₂ of thenon-absorbent 54. This configuration allows the ends of the urinaryincontinence device 50 to be exposed. The cover 70 also has a thicknessT₃ that is less than about 0.3 inches (about 7.6 mm). Preferably, thethickness T₃ of the cover 70 should be less than about 0.2 inches (about5 mm), and most preferably, the thickness T₃ is less than about 0.1inches (about 2.5 mm).

[0042] The cover 70 can be either liquid permeable orliquid-impermeable. Preferably, the cover 70 is liquid-impermeable. By“liquid-permeable” it is meant that body fluid is able to pass throughthe cover 70 in a quick and efficient manner. The cover 70 can behydrophilic, hydrophobic or a combination of each. By “hydrophilic” itis meant that the cover 70 has an affinity for absorbing or tending tocombine with water. By “hydrophobic” it is meant that the cover 70 isantagonistic to or tends not to combine with water. The cover 70 canalso be treated with a surfactant or some other chemical to make ithydrophilic, hydrophobic or to make it more hydrophilic or morehydrophobic. Surfactants having high lubricity and hydrophobicity andwhich are non-irritating to the vaginal mucosa are preferred since theydiscourage the attraction, accumulation and retention of any residentvaginal fluid.

[0043] When the cover 70 is liquid-impermeable, it serves to block bodyfluid from contacting the non-absorbent 54. Since the non-absorbent 54is not designed to absorb any body fluid, it is not necessary that thecover 70 be liquid-impermeable.

[0044] Liquid permeable materials include woven and nonwoven materialshaving a porous substrate. Woven materials include textile fabrics thatcan be made from rayon, cotton or polyolefins. The polyolefins can beeither staple or continuous filaments. The nonwoven materials caninclude spunbond, bonded-carded webs and hydroentangled webs. Onematerial that works well as a cover is a 0.4 ounces per square yard(osy) spunbond polypropylene having a crepe of at least 30 percent.Another material that works well as a cover is a 0.6 osy spunbondpolypropylene having a crepe of at least 30 percent. Spunbond andbonded-carded webs are commercially available from KimberlyClarkCorporation having an office at 401 N. Lake Street, Neenah, Wis. 54956.Another nonwoven material that can be used as the cover 70 is formedfrom 100 percent polyester fibers held together by a binder. Thismaterial is known as power-bonded-carded web (PBCW). PBCW iscommercially available from HDK Industries, Inc. having an office at 304Arcadia Drive, Greenville, S.C. 29609.

[0045] The cover 70 can also be constructed from a liquid-impermeablematerial. A good liquid-impermeable material is a micro-embossed,polymeric film, such as polyethylene or polypropylene. Bicomponent filmscan also be used. A preferred liquid-impermeable material ispolyethylene film. The cover 70 can further be formed from an aperturedthermoplastic film having either a two or three-dimensional thickness.Apertured thermoplastic films are available from several commercialvendors. One such vendor is Pantex srl, Pantex Sud srl, Via Terracinisnc, having an office at 51031 Agliana, Pistoia, Italy. A second vendoris Applied Extrusion Technology having a mailing address of P.O. Box582, Middleton, Del. 19709.

[0046] The cover 70 can also be treated with an aqueous solution toreduce frictional drag, to give the urinary incontinence device 50 apermanent wettability and/or to enhance the ease of insertion into andremoval from a woman's vagina.

[0047] Referring now to FIGS. 3-5, the resilient member 52, thenon-absorbent 54 and the cover 70 are rolled up or radially wound alongthe central longitudinal axis x-x into an elongated softwind 72. Thenon-absorbent 54, shown in FIG. 3, has points A and B located at thefirst and second ends, 60 and 62 respectively. Preferably, the threelayers 52, 54 and 70 are rolled or radially wound perpendicular to thex-x axis starting at point A and terminating at point B. The extralength of the cover 70, located adjacent to point B and extendingoutward therefrom, allows the cover 70 to wrap upon itself and providesthe softwind 72 with a smooth finished appearance. The softwind 72 has afirst end 74 and a second end 76 and possesses a non-uniformconfiguration between the first and second ends, 74 and 76 respectively.The resilient member 52 is located adjacent to the second end 76 andthis causes the second end 76 to have a diameter d₁ that is larger thanthe diameter d₂ of the first end 74. This larger diameter d₁ extendsback toward the first end 74 a distance approximately equal to the widthW₁ of the resilient member 52.

[0048] Referring to FIG. 5, the softwind 72 is then radially compressedalong the central transverse axis y-y into an elongated pledget 78having a generally cylindrical configuration. The pledget 78 has aninsertion end 80, a trailing end 82 and a uniform cross-sectional areatherebetween. The pledget 78 has a diameter d₃ that is generally smallerthan the diameter d₂ of the second end 74 of the softwind 72. Thediameter d₃ can range from between about 0.2 inches (about 5 mm) toabout 2 inches (about 51 mm). Preferably, the diameter d₃ of the pledget78 will be from about 0.5 inches (about 12.7 mm) to about 1 inch (about25.4 mm). Most preferably, the diameter d₃ of the pledget 78 is lessthan about 0.75 inches (about 19 mm).

[0049] A withdrawal means 84, preferably in the form of an elongatedstring or ribbon is securely attached to the pledget 78. The withdrawalstring 84 facilitates the removal of the urinary incontinence device 50from the vaginal canal 26. When the user is ready to remove the urinaryincontinence device 50, she will pull downward on the withdrawal string84. This action will cause the urinary incontinence device 50 to becomfortably withdrawn from the vaginal canal 26.

[0050] One way of securing the withdrawal string 84 to the pledget 78 isto form an aperture 86 transversely through the pledget 78 near thetrailing end 82. Preferably, the aperture 86 is spaced a short distancefrom the trailing end 82. The aperture 86 can be located a distance offrom between about 0.1 inches (about 2.5 mm) to about 0.5 inches (about12.7 mm) from the trailing end 82. Although the aperture 86 can belocated almost anywhere in the pledget 78, it preferably is locatedabout 0.25 inches (about 6.4 mm) from the trailing end 82. The aperture86 can be formed with a needle, an awl or some other type of piercingdevice known to those skilled in the art. The withdrawal string 84 isthen passed through the aperture 86. The withdrawal string 84 can belooped upon itself to form a secure attachment. The free ends of thewithdrawal string 84 are then tied in a knot 88 to assure that thewithdrawal string 84 will not separate from the urinary incontinencedevice 50. The knot 88 also serves to prevent fraying of the withdrawalstring 84 and to provide a place or point where a woman can grasp thewithdrawal string 84 when she is ready to remove the urinaryincontinence device 50 from her vagina 12. The compressed pledget 78with the withdrawal string 84 attached constitutes the finished urinaryincontinence device 50.

[0051] The withdrawal string 84 can be constructed from various types ofthreads or ribbons. A thread or ribbon made from 100 percent cottonfibers works well. The withdrawal string 84 should have a length whichextends beyond the trailing end 82 of the pledget 78 from between about2 inches (about 51 mm) to about 8 inches (about 203 mm). Preferably, thewithdrawal string 84 should have a length which extends beyond thetrailing end 82 from between about 4 inches (about 102 mm) to about 6inches (about 152 mm), and most preferably, by about 5 inches (about 127mm). The withdrawal string 84 can be dyed and/or treated with ananti-wicking agent, such as wax, before being secured to the urinaryincontinence device 50. The anti-wicking agent will reduce and hopefullyprevent body fluids from wicking along the withdrawal string 84 andcontacting the inner surface of a woman's undergarment. A dry, cleanwithdrawal string 84 is preferred by the user, especially when she goesto remove the urinary incontinence device 50 from her vagina 12.

[0052] The insertion end 80 of the urinary incontinence device 50 isdesigned to be the first part to enter a woman's vagina 12. Whenproperly inserted into the vagina 12, the entire urinary incontinencedevice 50 will be positioned in approximately the middle third of thelength of the vaginal canal 26. In other words, the urinary incontinencedevice 50 occupies approximately the middle 2 inches (about 51 mm) ofthe vaginal canal 26 and provides a supportive backdrop for the bodytissue and muscles located in the urethro-vaginal myofascial area 46. Inthis position, the urinary incontinence device 50 will be aligned withthe upper portion of the urethra 18 and will provide a supportivebackdrop for at least half of the urethra 18. During episodes ofincreased intra-abdominal pressure, the compression that occurs to theurethro-vaginal myofascial area 46 between the symphysis pubis 22 andthe urinary incontinence device 50 allows the sphincter muscles 44 toacquire a more normal configuration. The sphincter muscles 44 can thenoperate properly and the urethral 8 is capable of being compressed uponitself. These two functions assist one another in alleviatinginvoluntary urine flow from the bladder 20.

[0053] The insertion end 80 of the urinary incontinence device 50 iscapable of expanding radially outward. It is the expansion in the radialdirection that is the most important for this invention. The insertionend 80 can be designed to radially expand outward from between about 1.2to about 10 times the initial diameter d₃ of the pledget 78. Preferably,the insertion end 80 will be capable of radially expanding outward frombetween about 1.5 to about 4 times the initial diameter d₃ of thepledget 78. More preferably, the insertion end 80 will be capable ofradially expanding outward at least 2 times the diameter d₃ of thepledget 78. The maximum amount of radial expansion of the insertion end80 will depend on a number of factors, including the size, shape,location and composition of the resilient member 52, as well as thethickness and inherent properties of the non-absorbent 54 and the cover70. It is envisioned that one could design the urinary incontinencedevice 50 such that the insertion end 80 could radially expand more than10 times the initial diameter d₃ of the pledget 78, if desired.

[0054] The urinary incontinent device 50 will retain its generallycompressed cylindrical shape until it is positioned within the vagina12. To assist the urinary incontinent device 50 in retaining itscompressed shape, it can be housed in an applicator or be wrapped in athermoplastic wrapper.

[0055] It should be noted that when the urinary incontinence device 50is properly positioned in the vagina 12, only the withdrawal string 84will be exposed and extend outward from the introital opening 24.

[0056] Referring now to FIG. 6, the urinary incontinence device 50 isshown retained or housed in an applicator 90. The applicator 90 willfacilitate insertion of the urinary incontinence device 50 into awoman's vagina 12 and will assist in maintaining the uniformcross-sectional area of the pledget 78 until it is inserted into awoman's vagina. The applicator 90 can be identical to a tamponapplicator, if desired. The applicator 90 is depicted as a two-piecetelescoping applicator having a hollow outer tube 92 and a hollow innertube 94. The urinary incontinence device 50 is positioned within theouter tube 92 such that the inner tube 94, which has a smaller diameter,can be pushed against the trailing end 82. This action will cause theurinary incontinence device 50 to be expelled from the outer tube 92.The applicator 90 can be constructed of paper, cardboard or plastic. Oneexample of an applicator is taught in U.S. Pat. No. 5,795,346 whichissued to Achter et al. on Aug. 18, 1998 and is entitled: “TAMPON HAVINGA RESILIENT MEMBER.”

[0057] It should be recognized that the urinary incontinence device 50could also be digitally inserted into a woman's vagina 12. For digitalinsertion, a woman would use one of her fingers to push on the trailingend 82 of the urinary incontinence device 50 so that the insertion end80 could easily enter her vagina. With digital insertion, there would beno need for an applicator.

[0058] Referring now to FIGS. 7-9, an alternative embodiment of aurinary incontinence device 50′ is depicted. For the purpose of clarity,the numerals recited in FIGS. 3-5 will be used for this embodimentexcept that prime numbers will be used for new elements. The resilientmember 52′ is depicted as a member having a length L₄, a width W₄ and athickness T₄. The length L₄ of the resilient member 52′ is smaller thanthe length L₂ of the resilient member 52 by at least 50%. Preferably,the length L₄ of the resilient member 52′ is less than about 35% of thelength L₂ of the resilient member 52. The width W₄ of the resilientmember 52′ is greater than the width W₂ of the resilient member 52. Thewidth W₄ of the resilient member 52′ is about twice the width W₂ of theresilient member 52. The thickness T₄ of the resilient member 52′ isabout equal to the thickness T₂ of the resilient member 52.

[0059] The resilient member 52′ is positioned so as to straddle thecentral transverse axis y-y. However, it should be noted that theresilient member 52′ could be aligned adjacent to or near either thefirst end 60 or the second ends 62. By aligning the resilient member 52′closer to one of the first or second ends, 60 or 62 respectively, theposition of the resilient member 52′ in the rolled up softwind 72′ willchange. For example, if the resilient member 52′ is placed adjacent tothe first end 60 and the softwind 72′ is rolled up starting from pointA, the resilient member 52′ will be located next to the center of thesoftwind 72′. This location may make it more difficult for the resilientmember 52′ to radially expand outward. On the other hand, if theresilient member 52′ is placed adjacent to the second end 62 and thesoftwind 72′ was rolled up starting again at point A, the resilientmember 52′ will be located near the outer periphery of the softwind 72′.In this position, the resilient member 52′ could more easily expandradially outward.

[0060] Besides having a shorter length L₄ than the resilient member 52,the resilient member 52′ also differs from that shown in FIG. 3 in thatit has a greater width W₄. This increase in width W₄ will enlarge theexpansion area of the urinary incontinence device 50′. This enlargedexpansion area, denoted by W₄ in FIG. 8, is beneficial for a number ofreasons. First, the urinary incontinence device 50′ can be insertedfarther up the vaginal canal 26 while still being able to function as asupport for the urethro-vaginal myofascial area 46. Second, the enlargeddimension W₄ will contact a greater surface area of the inner periphery28 of the vaginal canal 26 and can therefore operate over a longer axialdimension. Third, by using the larger area of expansion, the urinaryincontinence device 50′ may be more comfortable for a woman to use whenproperly placed in her vagina 12.

[0061] Referring to FIGS. 8 and 9, one will notice that as the resilientmember 52′, the non-absorbent 54 and the cover 70, are rolled up orradially wound along the central longitudinal axis x-x, to form asoftwind 72′. The softwind 72′ has a greater area of expansion, denotedby the dimension W₄. The softwind 72′ has a first end 74′ and a secondend 76′ and possesses a non-uniform cross-section therebetween. Theresilient member 52′ is located adjacent to the second end 76′ of thesoftwind 72′ and this causes the second end 76′ to have a diameter d₄that is larger than the diameter d₅ of the first end 74′. This largerdiameter d₄ extends back toward the first end 74′ a distanceapproximately equal to the width W₄ of the resilient member 52′.

[0062] The softwind 72′ is then radially compressed along the centraltransverse axis y-y into an elongated pledget 78′ having a generallycylindrical configuration. The pledget 78′ has an insertion end 80′, atrailing end 82′ and a uniform cross-sectional area therebetween. Thepledget 78′ has a diameter d₆ that can range from between about 0.2inches (about 5 mm) to about 2 inches (about 51 mm). Preferably, thediameter d₆ of the pledget 78′ will be from about 0.5 inches (about 12.7mm) to about 1 inch (about 25.4 mm). Most preferably, the diameter d₆ ofthe pledget 78′ is less than about 0.75 inches (about 19 mm).

[0063] A withdrawal means 84, preferably in the form of an elongatedstring or ribbon is securely attached to the pledget 78′. The withdrawalstring 84 will function as described above with reference to the firstembodiment shown in FIGS. 3-6. The compressed pledget 78′ with thewithdrawal string 84 attached constitutes the finished urinaryincontinence device 50′.

[0064] The insertion end 80′ of the urinary incontinence device 50′ iscapable of expanding radially outward. It is the expansion in the radialdirection that is the most important for this invention. Since theresilient member 52′ is smaller in size than that depicted in the firstembodiment shown in FIGS. 3-6, the amount of expansion will be less. Theinsertion end 80′ can be designed to radially expand outward frombetween about 1.1 to about 4 times the initial diameter d₆ of thepledget 78′. Preferably, the insertion end 80′ will be capable ofradially expanding outward from between about 1.3 to about 3 times theinitial diameter d₆ of the pledget 78′. More preferably, the insertionend 80′ will be capable of radially expanding outward at least 1.4 timesthe diameter d₆ of the pledget 78′. The maximum amount of radialexpansion of the insertion end 80′ will depend on a number of factors,including the size, shape, location and composition of the resilientmember 52′, as well as the thickness and inherent properties of thenon-absorbent 54 and the cover 70. It is envisioned that one coulddesign the urinary incontinence device 50′ such that the insertion end80′ could radially expand more than 2 times the initial diameter d₆ ofthe pledget 78′, if desired.

Method

[0065] The method of forming the urinary incontinence device 50 or 50′for alleviating female urinary incontinence, especially during episodesof increased intra-abdominal pressure will now be explained withreference to the flow diagrams shown in FIGS. 10 and 11. The method willbe described with reference to the numerals denoted in FIG. 1, simplyfor ease of discussion, although it should be noted that the embodimentshown in FIG. 7 could also be utilized. The method includes the steps offorming a resilient member 52 into a desired geometrical shape. Theforming step can be by shaping, cutting, slitting or assembling theresilient member 52 into a predetermined configuration. A preferredshape for the resilient member 52 is an elongated strip or rectanglealthough other shapes, such as a square, an oval, an elliptical shape, aracetrack profile, etc. would work. The resilient member 52 can beformed from twisted, curled or chemically cross-linked cellulose fibersor a mixture thereof. Alternatively, the resilient member 52 can beformed from polyvinyl alcohol or from polyethylene oxide.

[0066] The resilient member 52 should have a predetermined length L₁, apredetermined width W₁, and a predetermined thickness T₁. The dimensionsof the length L₁, the width W₁, and the thickness T₁ can be varied tosuit one's desired product. The resilient member 52 has a side edge 68that is positioned on or adjacent to the side edge 64 of thenon-absorbent 54. Preferably, the side edge 68 of the resilient member52 is aligned so as to be coterminuous with the side edge 64 of thenon-absorbent 54. In addition, the resilient member 52 is positionedadjacent to, and preferably in direct contact with, the first surface 56of a non-absorbent 54 to form an assembly of two elements.Alternatively, an intermediate layer, such as one or more layers oftissue, can be placed therebetween, if desired.

[0067] The non-absorbent 54 is formed into a desired geometrical shapebefore the resilient member 52 is positioned adjacent to it. Thenon-absorbent 54 can be formed by cutting, shaping, slitting orassembling it into the desired configuration. A preferred configurationfor the non-absorbent 54 is a rectangle, although other shapes, such asa square, an oval, an elliptical shape, a racetrack profile, etc. wouldwork. The non-absorbent 54 has a predetermined length L₂, apredetermined width W₂ and a predetermined thickness T₂. Thenon-absorbent 54 has first and second surfaces, 56 and 58 respectively,which are spaced apart. The non-absorbent 54 also has a firstlongitudinal side edge 64 and a second longitudinal side edge 66. Thenon-absorbent 54 further has a central longitudinal axis x-x and acentral transverse axis y-y. For best results, the resilient member 52is aligned parallel to the central longitudinal axis x-x and ispositioned such that its side edge 68 is coterminously aligned with thefirst longitudinal side edge 64 of the non-absorbent 54. The resilientmember 52 can extend along the entire length L₂ of the non-absorbent 54or only along a portion of the length L₂ of the non-absorbent 54. Theresilient member 52 can have a length L₁ that ranges from between lessthan about 35% to about 100% of the length L₂ of the non-absorbent 54.

[0068] The resilient member 52 and the non-absorbent 54 are rolled upalong the longitudinal axis x-x into an elongated softwind 72. Thesoftwind 72 will have a first end 74, a second end 76 and a non-uniformcross-sectional area or configuration therebetween. When the side edge68 of the resilient member 52 is aligned with the longitudinal side edge64 of the non-absorbent 54, the resilient member 52 will be locatedadjacent to the second end 74 of the wound softwind 72. The softwind 72can have a diameter at one end that is at least 1.2 times greater thanthe diameter of the other end. Alternatively, the softwind 72 can have adiameter at one end that is at least 1.4 times greater than the diameterof the other end. The softwind 72 is then be compressed into a pledget78. The softwind 72 can be radially compressed to reduce itscircumference or the softwind 72 can be compressed both radially as wellas along its length. The pledget 78 has an insertion end 80, a trailingend 82 and a uniform cross-sectional area or configuration therebetween.

[0069] A withdrawal means 84, in the form of a string or ribbon, issecured to the pledget 78 to form a urinary incontinence device 50.Preferably, the withdrawal string 84 is securely connected to thepledget 78 approximate the trailing end 82. One way to accomplish thisis to form an aperture 86 through the pledget 78 approximate thetrailing end 82. The withdrawal string 84 is then passed through theaperture 86 and can be looped upon itself to form a secure connection.The finished urinary incontinence device 50 can be placed in a paper orplastic applicator 90 to facilitate insertion of the urinaryincontinence device 50 into a woman's vagina 12. The applicator 90 canbe telescopic in design using an inner tube and an outer tube. Theurinary incontinence device 50 is housed in the outer tube and isdispensed into a woman's vagina 12 by pressing on the inner tube. As theinner tube moves into the outer tube, it causes the urinary incontinencedevice 50 to be expelled therefrom.

[0070] Alternatively, the urinary incontinence device 50 can be wrappedin a thermoplastic film to help retain its shape until ready for use. Inthis embodiment, the user would remove the wrapper and digitally insertthe urinary incontinence device 50 into her vagina.

[0071] Referring again to FIGS. 3-5, it should be noted that the urinaryincontinence device 50 could contain a cover 70. The cover 70 can have alength L₃ that is greater than the length L₂ of the non-absorbent 54.The cover 70 can also be treated with a surfactant to render ithydrophobic. When a cover 70 is utilized, the resilient member 52 andthe non-absorbent 54 can be aligned and positioned on the cover 70 suchthat the non-absorbent 54 is adjacent to and preferably in directcontact with the cover 70. This means that the resilient member 52 willbe spaced apart from the cover 70. All three layers, the resilientmember 52, the non-absorbent 54 and the cover 70 can be rolled uptogether to form the elongated softwind 72. The entire softwind 72 willbe radially compressed into the pledget 78.

[0072] While the invention has been described in conjunction with twospecific embodiments, it is to be understood that many alternatives,modifications and variations will be apparent to those skilled in theart in light of the aforegoing description. Accordingly, this inventionis intended to embrace all such alternatives, modifications andvariations that fall within the spirit and scope of the appended claims.

I claim:
 1. A urinary incontinence device comprising: a) a resilientmember; and b) a non-absorbent positioned adjacent to said resilientmember, said non-absorbent being constructed from a fibrous materialwherein said fibers do not absorb significant quantities of moisturewithin said fibers, said non-absorbent and said resilient member beingrolled into an elongated softwind with said resilient member locatedadjacent to an end thereof, said softwind having a larger diameter atone end, said softwind being radially compressed into an elongatedpledget having an insertion end, a trailing end and a uniformcross-sectional area therebetween, and said resilient member capable ofexpanding said insertion end of said pledget to provide a supportivebackdrop for a woman's urethra when inserted into a woman's vagina. 2.The urinary incontinence device of claim 1 wherein said pledget has auniform cross-sectional area extending between said insertion end andsaid trailing end, and after being positioned in a woman's vagina, saidpledget exhibits a non-uniform cross-sectional area.
 3. The urinaryincontinence device of claim 1 wherein said resilient member is a closedcell foam.
 4. The urinary incontinence device of claim 1 wherein saidresilient member is an open cell foam.
 5. The urinary incontinencedevice of claim 1 wherein said non-absorbent has a first side edge and asecond side edge and said resilient member is positioned adjacent tosaid first side edge.
 6. The urinary incontinence device of claim 5wherein said resilient member is coterminuous with said first side edgeof said non-absorbent.
 7. The urinary incontinence device of claim 1wherein said non-absorbent has a longitudinal axis and said resilientmember is aligned parallel to said longitudinal axis.
 8. The urinaryincontinence device of claim 7 wherein said non-absorbent and saidresilient member are rolled along said longitudinal axis to form saidsoftwind having a non-uniform cross-sectional area.
 9. The urinaryincontinence device of claim 8 wherein one end of said softwind has adiameter that is at least 1.2 times greater than the diameter of saidother end.
 10. A urinary incontinence device comprising: a) a resilientmember; b) a non-absorbent positioned adjacent to said resilient member,said non-absorbent being constructed from a fibrous material whereinsaid fibers do not absorb significant quantities of moisture within saidfibers, said non-absorbent and said resilient member being rolled intoan elongated softwind with said resilient member located adjacent to anend thereof, said softwind having a larger diameter at one end, saidsoftwind being radially compressed into an elongated pledget having aninsertion end, a trailing end and a uniform cross-sectional areatherebetween, and said resilient member capable of expanding at least aportion of said insertion end of said pledget to provide a supportivebackdrop for a woman's urethra when inserted into a woman's vagina; andc) a withdrawal string secured to said pledget for facilitating removalof said urinary incontinence device from a woman's vagina.
 11. Theurinary incontinence device of claim 10 wherein an aperture is formedthrough said pledget approximate said trailing end and said withdrawalstring passes through said aperture.
 12. The urinary incontinence deviceof claim 10 wherein one end of said softwind has a diameter that is atleast 1.4 times greater than the diameter of said other end.
 13. Theurinary incontinence device of claim 10 wherein said resilient member isformed from twisted, curled, or chemically cross-linked cellulose fibersor a mixture thereof.
 14. The urinary incontinence device of claim 10wherein said resilient member is formed from polyvinyl alcohol.
 15. Theurinary incontinence device of claim 10 wherein said resilient member isformed from polyethylene oxide.
 16. A urinary incontinence devicecomprising: a) a resilient member; b) a non-absorbent positionedadjacent to said resilient member, said non-absorbent being constructedfrom a fibrous material wherein said fibers do not absorb significantquantities of moisture within said fibers, said non-absorbent and saidresilient member being rolled into an elongated softwind with saidresilient member located adjacent to an end thereof, said softwindhaving a larger diameter at one end, said softwind being radiallycompressed into an elongated pledget having an insertion end, a trailingend and a uniform cross-sectional area therebetween, and said resilientmember capable of expanding at least a portion of said insertion end ofsaid pledget to provide a supportive backdrop for a woman's urethra wheninserted into a woman's vagina; c) a cover at least partially enclosingsaid pledget; and d) a withdrawal string secured to said pledget forfacilitating removal of said urinary incontinence device from a woman'svagina.
 17. The urinary incontinence device of claim 16 wherein saidcover is positioned adjacent to said non-absorbent and is located awayfrom said resilient member.
 18. The urinary incontinence device of claim17 wherein said non-absorbent has a predetermined length and said coverhas a length greater than the length of said non-absorbent.
 19. Theurinary incontinence device of claim 16 wherein one end of said softwindhas a diameter that is at least 1.4 times greater than the diameter ofsaid other end.
 20. The urinary incontinence device of claim 16 whereinsaid cover is treated with a surfactant to render it hydrophobic.